Sandoz, Mylan gain FDA approval for generic Valtrex
PRINCETON, N.J. Sandoz announced Tuesday that it launched a generic drug for treating genital herpes.
The generics arm of Swiss drug maker Novartis said it launched valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths. The drug is a generic version of GlaxoSmithKline’s Valtrex, used to treat genital herpes, cold sores and shingles.
Mylan also announced Wednesday the Food and Drug Administration’s approval of its version of the drug.
Sales of branded and generic versions of the drug were around $2.2 billion during the 12-month period ended in March, according to IMS Health. Genital herpes affects at least 45 million people ages 12 years and older in the United States, according to the Centers for Disease Control and Prevention.